Hardware. Software. Risk. Compliance.
Change Impact Intelligence.
Firmware. Drawings. Suppliers. Production lots. The moment anything changes, EIS engineering automation surfaces every requirement, test, and risk control at risk — so you catch gaps before audits do, cut re-validation cycles, and get to market faster.
They trust us
Medical device teams change things constantly. The regulatory trail never keeps up.
A sensor swap, a firmware patch, a revised IFU — each one can invalidate a risk control, break a verification test, or trigger a new GSPR obligation. Right now, a QA engineer has to figure that out manually, across six systems, before the next submission or audit.
Change Impact Intelligence
Know what broke the moment something changes.
Firmware update or revised drawing — every affected requirement, test, and risk control flagged instantly. No manual triage.
Manufacturing & Supply
Know which units are at risk the moment a supplier flags a part.
Incoming inspection, DHR, and supplier certs all linked to the design record. When a batch fails, recall scope surfaces in seconds — not days of spreadsheet archaeology.
EU MDR Art. 83 — PMS
Field events assessed against your risk file. Automatically.
Complaints and vigilance reports classified against your ISO 14971 risk controls the moment they arrive. Know if an event crosses the threshold for a substantial change before the regulator asks.
ISO 13485 §8.5
Root cause from evidence, not forms.
Failed test → AI root cause → CAPA record. The full corrective loop closes automatically, with a full evidence trail.
ISO 13485 — NB Audit
Walk an auditor through clause-by-clause evidence. Live.
Navigate to any clause. Live AI verdicts, linked evidence. No 3-week prep sprint. No other tool owns this moment.
ISO 14971
A risk file that stays current.
Hazard → control → residual risk, re-evaluated on every design change. Not a spreadsheet. Not assembled once and forgotten.
IEC 62304
GitHub and Jira in your V&V map.
Commits, tickets, and test results in the same graph as your hardware drawings. One trace across the full V-model.
EU MDR
A Technical File from living data.
Annex I GSPR verdicts from live evidence. Not assembled the night before the audit. Continuously maintained.
| REQ | DWG | TST | FAT | |
|---|---|---|---|---|
| Design Inputs | ✓ | |||
| Design Outputs | ✓ | |||
| Verification | ✓ | ✓ | ||
| Validation | ✓ | ✓ | ✓ | |
| Design Review | ✓ | ✓ |
FDA QMSR
DHF structure, built from your project.
Inputs, outputs, verification, validation — linked and traceable. Exactly what FDA investigators check during a device inspection.
Plugs into your existing stack.
GitHub
Jira
IBM DOORS
TestRail
SolidWorks
Azure DevOps
SharePoint
SAP
Matrix Req
Confluence
Custom APIThe team
Built by alumni from
World-class research and industry backgrounds, united around the same mission.
